Long-term outcomes after treatment of delirium during critical illness with antipsychotics (MIND-USA): a randomised, placebo-controlled, phase 3 trial.

BACKGROUND: Delirium is common during critical illness and is associated with long-term cognitive impairment and disability. Antipsychotics are frequently used to treat delirium, but their effects on long-term outcomes are unknown. We aimed to investigate the effects of antipsychotic treatment of delirious, critically ill patients on long-term cognitive, functional, psychological, and quality-of-life outcomes. METHODS: This prespecified, long-term follow-up to the randomised, double-blind, placebo-controlled phase 3 MIND-USA Study was conducted in 16 hospitals throughout the USA. Adults (aged ≥18 years) who had been admitted to an intensive care unit with respiratory failure or septic or cardiogenic shock were eligible for inclusion in the study if they had delirium. Participants were randomly assigned-using a computer-generated, permuted-block randomisation scheme with stratification by trial site and age-in a 1:1:1 ratio to receive intravenous placebo, haloperidol, or ziprasidone for up to 14 days. Investigators and participants were masked to treatment group assignment. 3 months and 12 months after randomisation, we assessed survivors' cognitive, functional, psychological, quality-of-life, and employment outcomes using validated telephone-administered tests and questionnaires. This trial was registered with ClinicalTrials.gov, NCT01211522, and is complete. FINDINGS: Between Dec 7, 2011, and Aug 12, 2017, we screened 20 914 individuals, of whom 566 were eligible and consented or had consent provided to participate. Of these 566 patients, 184 were assigned to the placebo group, 192 to the haloperidol group, and 190 to the ziprasidone group. 1-year survival and follow-up rates were similar between groups. Cognitive impairment was common in all three treatment groups, with a third of survivors impaired at both 3-month and 12-month follow-up in all groups. More than half of the surveyed survivors in each group had cognitive or physical limitations (or both) that precluded employment at both 3-month and 12-month follow-up. At both 3 months and 12 months, neither haloperidol (adjusted odds ratio 1·22 [95% CI 0·73-2.04] at 3 months and 1·12 [0·60-2·11] at 12 months) nor ziprasidone (1·07 [0·59-1·96] at 3 months and 0·94 [0·62-1·44] at 12 months) significantly altered cognitive outcomes, as measured by the Telephone Interview for Cognitive Status T score, compared with placebo. We also found no evidence that functional, psychological, quality-of-life, or employment outcomes improved with haloperidol or ziprasidone compared with placebo. INTERPRETATION: In delirious, critically ill patients, neither haloperidol nor ziprasidone had a significant effect on cognitive, functional, psychological, or quality-of-life outcomes among survivors. Our findings, along with insufficient evidence of short-term benefit and frequent inappropriate continuation of antipsychotics at hospital discharge, indicate that antipsychotics should not be used routinely to treat delirium in critically ill adults. FUNDING: National Institutes of Health and the US Department of Veterans Affairs.

Impact of an enhanced recovery after surgery program with a multimodal analgesia care pathway on opioid prescribing and clinical outcomes for patients undergoing colorectal surgery.

Background: Opioids are a mainstay for acute pain management, but their side effects can adversely impact patient recovery. Multimodal analgesia (MMA) is recommended for treatment of postoperative pain and has been incorporated in enhanced recovery after surgery (ERAS) protocols. The objective of this quality improvement study was to implement an MMA care pathway as part of an ERAS program for colorectal surgery and to measure the effect of this intervention on patient outcomes and costs. Methods: This pre-post study included 856 adult inpatients who underwent an elective colorectal surgery at three hospitals within an integrated healthcare system. The impact of ERAS program implementation on opioid prescribing practices, outcomes, and costs was examined after adjusting for clinical and demographic confounders. Results: Improvements were seen in MMA compliance (34.0% vs 65.5%, P < 0.0001) and ERAS compliance (50.4% vs 57.6%, P < 0.0001). Reductions in mean days on opioids (4.2 vs 3.2), daily (51.6 vs 33.4 mg) and total (228.8 vs 112.7 mg) morphine milligram equivalents given during hospitalization, and risk-adjusted length of stay (4.3 vs 3.6 days, P < 0.05) were also observed. Conclusions: Implementing ERAS programs that include MMA care pathways as standard of care may result in more judicious use of opioids and reduce patient recovery time.

Post-acute sequelae of COVID-19 and longitudinal antibody levels in a community-based cohort.

BACKGROUND: Coronavirus disease 2019 (COVID-19) infection invokes variable immune responses and poses a risk of post-acute sequelae SARS-CoV-2 infection (PASC) symptoms; however, most data on natural history are derived from patients with severe infection. Further data are needed among patients with mild infection, who comprise most cases. METHODS: The Dallas Fort-Worth (DFW) COVID-19 Prevalence Study included 21,597 community-dwelling adults (ages 18-89) who underwent COVID-19 PCR and anti-nucleocapsid antibody testing between July 2020 and March 2021. We invited participants with positive COVID-19 results (cases) and a subset with negative results (controls), matched on age, sex, race/ethnicity, and ZIP code, to complete a follow-up questionnaire for PASC symptoms and repeat anti-nucleocapsid testing, and anti-spike antibody testing between July and December 2021. RESULTS: Of 3,917 adults invited to participate, 2260 (57.7%) completed the questionnaire- 1150 cases and 1110 controls. Persistent symptoms were reported in 21.1% of cases, with the most common being shortness of breath, fatigue, and loss of taste or smell. Among 292 cases with asymptomatic infection, >15% reported new fatigue and 8-10% reported new loss of taste/smell, myalgias, or headache. Median anti-nucleocapsid levels in cases decreased from 3.5U to 0.7U over a median follow-up of 8.6 months. Anti-spike antibody levels at 6-7 months post-vaccination in cases were similar to that of controls. CONCLUSIONS: More than 1 in 5 patients with COVID-19 infection, including those with mild infection, reported persistent symptoms during follow-up. Both nucleocapsid and spike protein antibody levels decreased within six months following a COVID-19 infection and vaccination.

Population-based correlates of COVID-19 infection: An analysis from the DFW COVID-19 prevalence study.

BACKGROUND: COVID-19 has resulted in over 1 million deaths in the U.S. as of June 2022, with continued surges after vaccine availability. Information on related attitudes and behaviors are needed to inform public health strategies. We aimed to estimate the prevalence of COVID-19, risk factors of infection, and related attitudes and behaviors in a racially, ethnically, and socioeconomically diverse urban population. METHODS: The DFW COVID-19 Prevalence Study Protocol 1 was conducted from July 2020 to March 2021 on a randomly selected sample of adults aged 18-89 years, living in Dallas or Tarrant Counties, Texas. Participants were asked to complete a 15-minute questionnaire and COVID-19 PCR and antibody testing. COVID-19 prevalence estimates were calculated with survey-weighted data. RESULTS: Of 2969 adults who completed the questionnaire (7.4% weighted response), 1772 (53.9% weighted) completed COVID-19 testing. Overall, 11.5% of adults had evidence of COVID-19 infection, with a higher prevalence among Hispanic and non-Hispanic Black persons, essential workers, those in low-income neighborhoods, and those with lower education attainment compared to their counterparts. We observed differences in attitudes and behaviors by race and ethnicity, with non-Hispanic White persons being less likely to believe in the importance of mask wearing, and racial and ethnic minorities more likely to attend social gatherings. CONCLUSION: Over 10% of an urban population was infected with COVID-19 early during the pandemic. Differences in attitudes and behaviors likely contribute to sociodemographic disparities in COVID-19 prevalence.

The Texas Health Resources Clinical Scholars Program: Learning healthcare system workforce development through embedded translational research.

Introduction: Texas Health Resources (THR), a large, nonprofit health care system based in the Dallas-Fort Worth area, has collaborated with the University of Texas Southwestern Medical Center (UTSW) to develop and operate a unique, integrated approach for Learning Health System (LHS) workforce development. This training model centers on academic health system faculty members conducting later-stage translational research within a partnering regional care delivery organization. Methods: The THR Clinical Scholars Program engages early career UTSW faculty members to conduct studies that are likely to have an impact on care delivery at the health system level. Interested candidates submit formal applications to the program. A joint committee comprised of senior research faculty from UTSW and THR clinical leadership reviews proposals with a focus on the shared LHS needs of both institutions-developing high quality research output that can be applied to enhance care delivery. A key prioritization criterion for funding is the degree to which the research addresses a question relevant to THR as a high-volume network with multiple channels for consumers to access care. The program emphasis is on supporting embedded research initiatives using health system data to generate knowledge that will improve the quality and efficiency of care for the patient populations served by the participant organizations. Results: We discuss specific strategic and tactical components of the THR Clinical Scholars Program including an overview of the academic affiliation agreement between the collaborating organizations, criteria for successful program applications, data sharing, and funding. We also share project summaries from selected clinical scholars as examples of the LHS research done in the program to date. Conclusion: This experience report provides an implementation framework for other academic health systems interested in adopting similar LHS workforce training models with community partners.

Retrospective observational study of asthma and chronic obstructive pulmonary disease prevalence and associated healthcare resource utilization in a large, integrated healthcare system.

Limited data exist on asthma and chronic obstructive pulmonary disease (COPD) management-major drivers of healthcare resource utilization (HCRU) in the USA. We describe prevalence and exacerbation rates, therapeutic interventions, and HCRU for asthma and/or COPD within a large, integrated healthcare system. Patients with asthma, COPD, and asthma + COPD were identified from retrospective electronic health record data (2016-2018) of >1.7 million patients. Descriptive analysis of disease prevalence and exacerbation frequencies, pharmacotherapies, and HCRU was performed. Time-to-event analysis of time to first exacerbation was performed in patients with asthma and/or COPD. Exacerbation rates, pharmacotherapies, and HCRU were examined by exploratory analysis in an outpatient subset. Overall, 149,086 unique patients (8.6%) had encounters for asthma, COPD, or asthma + COPD. Acute care utilization was high, including emergency department visits (asthma, 52.9%; COPD, 35.1%) and hospitalizations (asthma, 26.7%; COPD, 65.7%). Many patients were prescribed short-acting therapies (asthma, 45.3%; COPD, 40.0%; asthma + COPD, 54.7%). Prescription rates for maintenance therapies were low (17.1%, 20.8%, 31.7%) and annual exacerbation rates were 0.65, 0.80, and 1.33. This analysis showed a substantive prevalence of pulmonary disease, variability between documented prescriptions and pharmacotherapy guidelines, and high HCRU. Appropriate tailoring of pharmacotherapies and management of asthma and COPD over a continuum are opportunities to improve patient care.

Effectiveness of an algorithm-based care pathway for patients with non-valvular atrial fibrillation presenting to the emergency department.

OBJECTIVE: Atrial fibrillation (AF) carries substantial morbidity and mortality. Evidence-based guidelines have been synthesized into emergency department (ED) AF care pathways, but the effectiveness and scalability of such approaches are not well established. We thus evaluated the impacts of an algorithmic care pathway for ED management of non-valvular AF (EDAFMP) on hospital use and care process measures. METHODS: We deployed a voluntary-use EDAFMP in 4 EDs (1 tertiary hospital, 1 cardiac hospital, 2 community hospitals) of an integrated delivery organization using a multifaceted implementation approach. We compared outcomes between patients with AF treated using the EDAFMP and historical and contemporaneous "usual care" controls, using a propensity-score adjusted generalized estimating equation. Patients with an index ED encounter for a primary visit reason of non-valvular AF (and no excluding concurrent diagnoses) were eligible for inclusion. RESULTS: Preimplementation (January 1, 2016-December 31, 2016), 628 AF patients were eligible; postimplementation (September 1, 2017-June 30, 2019), 1296, including 271 (20.9%) treated with the EDAFMP, were eligible. EDAFMP patients were less likely to be admitted than both historical (adjusted odds ratio [aOR], 95% confidence interval [CI]: 0.45, 0.29-0.71) and contemporaneous controls (aOR, 95%CI: 0.63, 0.46-0.86). ED visits and hospital readmissions over 90 days subsequent to index ED encounters were similar between postimplementation EDAFMP and usual care groups. EDAFMP patients were more likely to be prescribed anticoagulation (38% v. 5%, P < 0.001) and be referred to a cardiologist (93% vs 29%, P < 0.001) versus the comparator group. CONCLUSION: EDAFMP use is associated with decreased hospital admission during an index ED encounter for non-valvular AF, and improved delivery of AF care processes.

Association of Healthcare Access With Intensive Care Unit Utilization and Mortality in Patients of Hispanic Ethnicity Hospitalized With COVID-19.

BACKGROUND: Racial and ethnic minority groups in the United States experience a disproportionate burden of COVID-19 deaths. OBJECTIVE: To evaluate whether outcome differences between Hispanic and non-Hispanic COVID-19 hospitalized patients exist and, if so, to identify the main malleable contributing factors. DESIGN, SETTING, PARTICIPANTS: Retrospective, cross-sectional, observational study of 6097 adult COVID-19 patients hospitalized within a single large healthcare system from March to November 2020. EXPOSURES: Self-reported ethnicity and primary language. MAIN OUTCOMES AND MEASURES: Clinical outcomes included intensive care unit (ICU) utilization and in-hospital death. We used age-adjusted odds ratios (OR) and multivariable analysis to evaluate the associations between ethnicity/language groups and outcomes. RESULTS: 32.1% of patients were Hispanic, 38.6% of whom reported a non-English primary language. Hispanic patients were less likely to be insured, have a primary care provider, and have accessed the healthcare system prior to the COVID-19 admission. After adjusting for age, Hispanic inpatients experienced higher ICU utilization (non-English-speaking: OR, 1.75; 95% CI, 1.47-2.08; English-speaking: OR, 1.13; 95% CI, 0.95-1.33) and higher mortality (non-English-speaking: OR, 1.43; 95% CI, 1.10-1.86; English-speaking: OR, 1.53; 95% CI, 1.19-1.98) compared to non-Hispanic inpatients. There were no observed treatment disparities among ethnic groups. After adjusting for age, Hispanic inpatients had elevated disease severity at admission (non-English-speaking: OR, 2.27; 95% CI, 1.89-2.72; English-speaking: OR, 1.33; 95% CI, 1.10- 1.61). In multivariable analysis, the associations between ethnicity/language and clinical outcomes decreased after considering baseline disease severity (P < .001). CONCLUSION: The associations between ethnicity and clinical outcomes can be explained by elevated disease severity at admission and limited access to healthcare for Hispanic patients, especially non-English-speaking Hispanics.

Implementation and Routinization of the ABCDE Bundle: A Mixed Methods Evaluation.

BACKGROUND: The ABCDE (Awakening and Breathing Coordination, Delirium monitoring and management, and Early exercise/mobility) bundle has been associated with reductions in delirium incidence and improved patient outcomes but has not been widely adopted. OBJECTIVE: The objective of this study was to determine how to facilitate ABCDE bundle adoption by examining the impact of different implementation strategies on bundle adherence rates and assessing clinicians' perceptions of the bundle and implementation efforts. METHODS: This study examined the effect of 2 bundle implementation strategies on patient care in 8 adult intensive care units. The basic strategy included electronic health record (EHR) modification, whereas the enhanced strategy included EHR modification plus additional bundle training, clinical champions, and staff engagement. A total of 84 nurses, physicians, and therapists participated in interviews and a survey to assess bundle implementation. RESULTS: Respondents indicated bundle use resulted in "best care" through care standardization and coordination and improved patient outcomes. Intensive care units in both intervention groups had significant improvements in bundle adherence after implementation efforts, but intensive care units in the basic intervention group outperformed other sites after initiating their own implementation strategies. Successful implementation tactics included incorporating the bundle into multidisciplinary rounds and providing ongoing support, training, and routine auditing and feedback. DISCUSSION: The ABCDE bundle can improve quality of care and outcomes, and implementation can be accelerated through EHR tools, trainings, and performance feedback.

Embedded Health Systems Science as a driver of care improvement within an integrated delivery organization.

BACKGROUND: Embedded Health Systems Science (HSS) has the potential to reduce gaps between research and delivery of evidence-based medicine. Models are needed to guide the development of embedded HSS in health care delivery organizations particularly with the rise of value-based care. METHODS: The development of HSS infrastructure at a large nonprofit health care delivery organization is described, along with an embedded HSS diabetes study to illustrate the integration of program specific data, electronic health records, and health care system data infrastructure. To compare diabetes outcomes across four evidenced-based programs, a control group was developed from EHR data using propensity score matching. Mixed effect adjusted models were used to estimate reductions in hemoglobin A1c (HbA1c) and body weight. RESULTS: Adjusted analyses using an EHR derived comparison group demonstrated significantly different findings than unadjusted pre to post analyses. The embedded HSS study indicates that appropriate statistical methods, staff with required expertise, and integration with health system data infrastructure are needed to develop timely and rigorous HSS outcomes that effectively improve patient care. CONCLUSIONS: Embedded HSS has the potential to inform value-based care models and contribute to evidence-based medicine approaches that improve patient care. Although developing system wide integrated data structures and staff with the appropriate skills requires substantial effort, the outcome is more reliable evaluations that lead to higher quality and higher value care. IMPLICATIONS: Health care delivery organizations can improve patient care by dedicating resources to embed HSS into its routine operations.

Evaluating the Cost-Effectiveness of the ABCDE Bundle: Impact of Bundle Adherence on Inpatient and 1-Year Mortality and Costs of Care.

OBJECTIVES: Growing evidence supports the Awakening and Breathing Coordination, Delirium monitoring/management, and Early exercise/mobility (ABCDE) bundle processes as improving a number of short- and long-term clinical outcomes for patients requiring ICU care. To assess the cost-effectiveness of this intervention, we determined the impact of ABCDE bundle adherence on inpatient and 1-year mortality, quality-adjusted life-years, length of stay, and costs of care. DESIGN: We conducted a 2-year, prospective, cost-effectiveness study in 12 adult ICUs in six hospitals belonging to a large, integrated healthcare delivery system. SETTING: Hospitals included a large, urban tertiary referral center and five community hospitals. ICUs included medical/surgical, trauma, neurologic, and cardiac care units. PATIENTS: The study included 2,953 patients, 18 years old or older, with an ICU stay greater than 24 hours, who were on a ventilator for more than 24 hours and less than 14 days. INTERVENTION: ABCDE bundle. MEASUREMENTS AND MAIN RESULTS: We used propensity score-adjusted regression models to determine the impact of high bundle adherence on inpatient mortality, discharge status, length of stay, and costs. A Markov model was used to estimate the potential effect of improved bundle adherence on healthcare costs and quality-adjusted life-years in the year following ICU admission. We found that patients with high ABCDE bundle adherence (≥ 60%) had significantly decreased odds of inpatient mortality (odds ratio 0.28) and significantly higher costs ($3,920) of inpatient care. The incremental cost-effectiveness ratio of high bundle adherence was $15,077 (95% CI, $13,675-$16,479) per life saved and $1,057 per life-year saved. High bundle adherence was associated with a 0.12 increase in quality-adjusted life-years, a $4,949 increase in 1-year care costs, and an incremental cost-effectiveness ratio of $42,120 per quality-adjusted life-year. CONCLUSIONS: The ABCDE bundle appears to be a cost-effective means to reduce in-hospital and 1-year mortality for patients with an ICU stay.

Model for End-Stage Liver Disease-Lactate and Prediction of Inpatient Mortality in Patients With Chronic Liver Disease.

BACKGROUND AND AIMS: Compared to other chronic diseases, patients with chronic liver disease (CLD) have significantly higher inpatient mortality; accurate models to predict inpatient mortality are lacking. Serum lactate (LA) may be elevated in patients with CLD due to both tissue hypoperfusion as well as decreased LA clearance. We hypothesized that a parsimonious model consisting of Model for End-Stage Liver Disease (MELD) and LA at admission may predict inpatient mortality in patients with CLD. APPROACH AND RESULTS: We examined all patients with CLD in two large and diverse health care systems in Texas (North Texas [NTX] and Central Texas [CTX]) between 2010 and 2015. We developed (n = 3,588) and validated (n = 1,804) a model containing MELD and LA measured at the time of hospitalization. We further validated the model in a second cohort of 14 tertiary care hepatology centers that prospectively enrolled nonelective hospitalized patients with cirrhosis (n = 726). MELD-LA was an excellent predictor of inpatient mortality in development (concordance statistic [C-statistic] = 0.81, 95% confidence interval [CI] 0.79-0.82) and both validation cohorts (CTX cohort, C-statistic = 0.85, 95% CI 0.78-0.87; multicenter cohort C-statistic = 0.82, 95% CI 0.74-0.88). MELD-LA performed especially well in patients with specific cirrhosis diagnoses (C-statistic = 0.84, 95% CI 0.81-0.86) or sepsis (C-statistic = 0.80, 95% CI 0.78-0.82). For MELD score 25, inpatient mortality rates were 11.2% (LA = 1 mmol/L), 19.4% (LA = 3 mmol/L), 34.3% (LA = 5 mmol/L), and >50% (LA > 8 mmol/L). A linear increase (P < 0.01) was seen in MELD-LA and increasing number of organ failures. Overall, use of MELD-LA improved the risk prediction in 23.5% of patients compared to MELD alone. CONCLUSIONS: MELD-LA (bswh.md/meldla) is an early and objective predictor of inpatient mortality and may serve as a model for risk assessment and guide therapeutic options.

Innovative Data Science to Transform Health Care: All the Pieces Matter.

This issue of eGEMS focuses on application of data science as a driver of health care transformation. Importantly, quantitative or qualitative analysis with a particular method is only one downstream step in the process of leveraging data. Effective analytics occurs on a continuum with multiple complementary phases, categorized here as data acquisition, ensuring or enhancing data access and usability, data analysis, and dissemination. Each of these activities is encompassed in the series of papers presented.

Haloperidol and Ziprasidone for Treatment of Delirium in Critical Illness.

BACKGROUND: There are conflicting data on the effects of antipsychotic medications on delirium in patients in the intensive care unit (ICU). METHODS: In a randomized, double-blind, placebo-controlled trial, we assigned patients with acute respiratory failure or shock and hypoactive or hyperactive delirium to receive intravenous boluses of haloperidol (maximum dose, 20 mg daily), ziprasidone (maximum dose, 40 mg daily), or placebo. The volume and dose of a trial drug or placebo was halved or doubled at 12-hour intervals on the basis of the presence or absence of delirium, as detected with the use of the Confusion Assessment Method for the ICU, and of side effects of the intervention. The primary end point was the number of days alive without delirium or coma during the 14-day intervention period. Secondary end points included 30-day and 90-day survival, time to freedom from mechanical ventilation, and time to ICU and hospital discharge. Safety end points included extrapyramidal symptoms and excessive sedation. RESULTS: Written informed consent was obtained from 1183 patients or their authorized representatives. Delirium developed in 566 patients (48%), of whom 89% had hypoactive delirium and 11% had hyperactive delirium. Of the 566 patients, 184 were randomly assigned to receive placebo, 192 to receive haloperidol, and 190 to receive ziprasidone. The median duration of exposure to a trial drug or placebo was 4 days (interquartile range, 3 to 7). The median number of days alive without delirium or coma was 8.5 (95% confidence interval [CI], 5.6 to 9.9) in the placebo group, 7.9 (95% CI, 4.4 to 9.6) in the haloperidol group, and 8.7 (95% CI, 5.9 to 10.0) in the ziprasidone group (P=0.26 for overall effect across trial groups). The use of haloperidol or ziprasidone, as compared with placebo, had no significant effect on the primary end point (odds ratios, 0.88 [95% CI, 0.64 to 1.21] and 1.04 [95% CI, 0.73 to 1.48], respectively). There were no significant between-group differences with respect to the secondary end points or the frequency of extrapyramidal symptoms. CONCLUSIONS: The use of haloperidol or ziprasidone, as compared with placebo, in patients with acute respiratory failure or shock and hypoactive or hyperactive delirium in the ICU did not significantly alter the duration of delirium. (Funded by the National Institutes of Health and the VA Geriatric Research Education and Clinical Center; MIND-USA ClinicalTrials.gov number, NCT01211522 .).

Increasing Health Care Burden of Chronic Liver Disease Compared With Other Chronic Diseases, 2004-2013.

BACKGROUND & AIMS: Chronic liver disease (CLD) is a common and expensive condition, and studies of CLD-related hospitalizations have underestimated the true burden of disease. We analyzed data from a large, diverse health care system to compare time trends in CLD-related hospitalizations with those in congestive heart failure (CHF) or chronic obstructive pulmonary disease (COPD). METHODS: We collected data from a large health care system in Texas on hospitalizations related to CLD (n = 27,783), CHF (n = 60,415), and COPD (n = 34,199) from January 1, 2004 through December 31, 2013. We calculated annual hospitalization rates (per 100,000) and compared hospital course, inpatient mortality, ancillary services, and readmissions. RESULTS: Compared with patients with CHF (median age, 71 years) or COPD (median age, 69 years), patients with CLD were significantly younger (median age, 57 years) (P < .01 vs CHF and COPD). Higher proportions of patients with CLD were uninsured (11.7% vs 5.4% for CHF and 5.4% for COPD, P < .01) and Hispanic (17% for CLD vs 9.3% for CHF and 5.0% for COPD, P < .01). A lower proportion of patients with CLD had Medicare (41.5% vs 68.6% with CHF and 70.1% with COPD, P < .01). From 2004 through 2013, the rate of CLD-related hospitalization increased by 92% (from 1295/100,000 to 2490/100,000), compared with 6.7% for CHF (from 3843/100,000 to 4103/100,000) and 48.8% for COPD (from 1775/100,000 to 2642/100,000). During this time period, CLD-related hospitalizations covered by Medicare increased from 31.8% to 41.5%, whereas hospitalizations covered by Medicare did not change for CHF (remained at 70%) or COPD (remained at 70%). Patients with CLD had longer hospital stays (7.3 days vs 6.2 days for CHF and 5.9 days for COPD, P < .01). A higher proportion of patients with CLD died or were discharged to hospice (14.2% vs 11.5% of patients with CHF and 9.3% of patients with COPD, P < .01), and a smaller proportion had access to postacute care (13.2% vs 23.2% of patients with CHF and 27.4% of patients with COPD, P < .01). A higher proportion of patients with CLD were readmitted to the hospital within 30 days (25% vs 21.9% of patients with CHF and 20.6% with COPD, P < .01). CONCLUSIONS: Patients with CLD, compared with selected other chronic diseases, had increasing rates of hospitalization, longer hospital stays, more readmissions, and, despite these adverse outcomes, less access to postacute care. Disease management models for CLD are greatly needed to manage the anticipated increase in hospitalizations for CLD.

Association of Opioid-Related Adverse Drug Events With Clinical and Cost Outcomes Among Surgical Patients in a Large Integrated Health Care Delivery System.

Importance: Opioids are commonly used for pain control during and after invasive procedures. However, opioid-related adverse drug events (ORADEs) are common and have been associated with worse patient outcomes. Objectives: To examine the incidence of ORADEs in patients undergoing hospital-based surgical and endoscopic procedures and to evaluate the association of ORADEs with clinical and cost outcomes. Design, Setting, and Participants: In this retrospective study of clinical and administrative data, ORADEs were identified using International Classification of Diseases, Ninth Revision diagnosis codes for known adverse effects of opioids or by opioid antagonist use. Multivariable regression analysis was used to measure the association of ORADEs with outcomes after adjusting for potential confounding factors. The setting was 21 acute care hospitals in a large integrated health care delivery system. Participants were 135 379 patients (aged ≥18 years, admitted from January 1, 2013, to September 30, 2015) who underwent surgical and endoscopic procedures and were given opioids. Exposure: Opioid use, reported as morphine milligram equivalent doses. Main Outcomes and Measures: Opioid-related adverse drug events and their association with inpatient mortality, discharge to another care facility, length of stay, cost of hospitalization, and 30-day readmission. Results: Among 135 379 adult patients in this study (67.5% female), 14 386 (10.6%) experienced at least one ORADE. Patients with ORADEs were more likely to be older, of white race/ethnicity, and male and have more comorbidities. Patients with ORADEs received a higher total dose of opioids (median morphine milligram equivalent dose, 46.8 vs 30.0 mg; P < .001) and for a longer duration (median, 3.0 vs 2.0 days; P < .001). In adjusted analyses, ORADEs were associated with increased inpatient mortality (odds ratio [OR], 28.8; 95% CI, 24.0-34.5), greater likelihood of discharge to another care facility (OR, 2.9; 95% CI, 2.7-3.0), prolonged length of stay (OR, 3.1; 95% CI, 2.8-3.4), high cost of hospitalization (OR, 2.7; 95% CI, 2.4-3.0), and higher rate of 30-day readmission (OR, 1.3; 95% CI, 1.2-1.4). ORADEs were associated with a 2.9% increase in absolute mortality, an $8225 increase in cost for the index hospitalization, and a 1.6-day increase in length of stay for the index hospitalization. Conclusions and Relevance: Opioid-related adverse drug events were common among patients undergoing hospital-based invasive procedures and were associated with significantly worse clinical and cost outcomes. Hospital-acquired harm from ORADEs in the surgical patient population is an important opportunity for health systems to improve patient safety and reduce cost.

Long-Term Outcomes From Repeated Smoking Cessation Assistance in Routine Primary Care.

PURPOSE: To test the association between repeated clinical smoking cessation support and long-term cessation. DESIGN: Retrospective, observational cohort study using structured and free-text data from electronic health records. SETTING: Six diverse health systems in the United States. PARTICIPANTS: Patients aged ≥18 years who were smokers in 2007 and had ≥1 primary care visit in each of the following 4 years (N = 33 691). MEASURES: Primary exposure was a composite categorical variable (comprised of documentation of smoking cessation medication, counseling, or referral) classifying the proportions of visits for which patients received any cessation assistance (<25% (reference), 25%-49%, 50%-74%, and ≥75% of visits). The dependent variable was long-term quit (LTQ; yes/no), defined as no indication of being a current smoker for ≥365 days following a visit where nonsmoker or former smoker was indicated. ANALYSIS: Mixed effects logistic regression analysis adjusted for age, sex, race, and comorbidities, with robust standard error estimation to account for within site correlation. RESULTS: Overall, 20% of the cohort achieved LTQ status. Patients with ≥75% of visits with any assistance had almost 3 times the odds of achieving LTQ status compared to those with <25% visits with assistance (odds ratio = 2.84; 95% confidence interval: 1.50-5.37). Results were similar for specific assistance types. CONCLUSIONS: These findings provide support for the importance of repeated assistance at primary care visits to increase long-term smoking cessation.

Early inpatient calculation of laboratory-based 30-day readmission risk scores empowers clinical risk modification during index hospitalization.

Improving 30-day readmission continues to be problematic for most hospitals. This study reports the creation and validation of sex-specific inpatient (i) heart failure (HF) risk scores using electronic data from the beginning of inpatient care for effective and efficient prediction of 30-day readmission risk. METHODS: HF patients hospitalized at Intermountain Healthcare from 2005 to 2012 (derivation: n=6079; validation: n=2663) and Baylor Scott & White Health (North Region) from 2005 to 2013 (validation: n=5162) were studied. Sex-specific iHF scores were derived to predict post-hospitalization 30-day readmission using common HF laboratory measures and age. Risk scores adding social, morbidity, and treatment factors were also evaluated. RESULTS: The iHF model for females utilized potassium, bicarbonate, blood urea nitrogen, red blood cell count, white blood cell count, and mean corpuscular hemoglobin concentration; for males, components were B-type natriuretic peptide, sodium, creatinine, hematocrit, red cell distribution width, and mean platelet volume. Among females, odds ratios (OR) were OR=1.99 for iHF tertile 3 vs. 1 (95% confidence interval [CI]=1.28, 3.08) for Intermountain validation (P-trend across tertiles=0.002) and OR=1.29 (CI=1.01, 1.66) for Baylor patients (P-trend=0.049). Among males, iHF had OR=1.95 (CI=1.33, 2.85) for tertile 3 vs. 1 in Intermountain (P-trend <0.001) and OR=2.03 (CI=1.52, 2.71) in Baylor (P-trend < 0.001). Expanded models using 182-183 variables had predictive abilities similar to iHF. CONCLUSIONS: Sex-specific laboratory-based electronic health record-delivered iHF risk scores effectively predicted 30-day readmission among HF patients. Efficient to calculate and deliver to clinicians, recent clinical implementation of iHF scores suggest they are useful and useable for more precise clinical HF treatment.

The High Value Healthcare Collaborative: Observational Analyses of Care Episodes for Hip and Knee Arthroplasty Surgery.

BACKGROUND: Broader use of value-based reimbursement models will require providers to transparently demonstrate health care value. We sought to determine and report cost and quality data for episodes of hip and knee arthroplasty surgery among 13 members of the High Value Healthcare Collaborative (HVHC), a consortium of health care systems interested in improving health care value. METHODS: We conducted a retrospective, cross-sectional observational cohort study of 30-day episodes of care for hip and knee arthroplasty in fee-for-service Medicare beneficiaries aged 65 or older who had hip or knee osteoarthritis and used 1 of 13 HVHC member systems for uncomplicated primary hip arthroplasty (N = 8853) or knee arthroplasty (N = 16,434), respectively, in 2012 or 2013. At the system level, we calculated: per-capita utilization rates; postoperative complication rates; standardized total, acute, and postacute care Medicare expenditures for 30-day episodes of care; and the modeled impact of reducing episode expenditures or per-capita utilization rates. RESULTS: Adjusted per-capita utilization rates varied across HVHC systems and postacute care reimbursements varied more than 3-fold for both types of arthroplasty in both years. Regression analysis confirmed that total episode and postacute care reimbursements significantly differed across HVHC members after considering patient demographic differences. Potential Medicare cost savings were greatest for knee arthroplasty surgery and when lower total reimbursement targets were achieved. CONCLUSION: The substantial variation that we found offers opportunities for learning and collaboration to collectively improve outcomes, reduce costs, and enhance value. Ceteris paribus, reducing per-episode reimbursements would achieve greater Medicare cost savings than reducing per-capita rates.